AstraZeneca Secures Global Rights to Dizal’s Oral EGFR Inhibitor Zegfrovy for Lung Cancer

(IN BRIEF) AstraZeneca has entered into an exclusive global licence agreement with Dizal Pharmaceutical for Zegfrovy, also known as sunvozertinib, an oral irreversible EGFR inhibitor for lung cancer. The deal gives AstraZeneca worldwide rights to develop and commercialise the medicine. Zegfrovy is already approved in the United States and China for adult patients with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations, after progression on or after platinum-based chemotherapy. AstraZeneca said the medicine complements its existing portfolio for EGFR-mutated lung cancer. The agreement includes a $600 million upfront payment to Dizal, up to $900 million in potential milestone payments, and tiered royalties on global sales. The transaction is expected to close in the second half of 2026, subject to customary conditions and regulatory clearances.

(PRESS RELEASE) CAMBRIDGE, 14-Jul-2026 — /EuropaWire/ — AstraZeneca has entered into an exclusive global licence agreement with Dizal Pharmaceutical Co., Ltd. for Zegfrovy, also known as sunvozertinib, a novel oral irreversible epidermal growth factor receptor inhibitor developed for patients with lung cancer.

Under the agreement, AstraZeneca will acquire worldwide rights to develop and commercialise Zegfrovy, further strengthening its portfolio of medicines targeting EGFR mutations in lung cancer.

Zegfrovy is approved in the United States and China for adult patients with locally advanced or metastatic non-small cell lung cancer whose tumours carry EGFR exon 20 insertion mutations and whose disease has progressed during or after platinum-based chemotherapy.

Non-small cell lung cancer accounts for around 80% to 85% of lung cancer cases globally. EGFR-mutated non-small cell lung cancer is found in approximately 10% to 15% of NSCLC patients in the United States and Europe, and in around 30% to 40% of patients in Asia.

AstraZeneca said roughly one in four patients with EGFR-mutated NSCLC has a tumour with an exon 20 insertion mutation or another atypical mutation, areas where targeted treatment options remain limited.

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit at AstraZeneca, said the agreement will add an important medicine to the company’s lung cancer portfolio.

“AstraZeneca is a leader in treating EGFR-mutated lung cancer, and we are eager to add Zegfrovy to our world-class portfolio of innovative medicines for patients whose tumours carry exon 20 insertion mutations,” said Fredrickson. “With this agreement, we will bring a differentiated, oral targeted treatment to these patients with limited options across the globe.”

Dr Xiaolin Zhang, Chief Executive Officer of Dizal, said AstraZeneca’s global lung cancer expertise will help expand access to the medicine.

“As a leading global company with a strong lung cancer franchise, AstraZeneca will help ensure patients around the world can benefit from this innovation discovered by Dizal scientists in China,” said Zhang.

He added that Zegfrovy is the only oral targeted therapy for EGFR exon 20 insertion non-small cell lung cancer approved in the United States and China for patients following prior systemic therapy.

Dizal recently reported positive results from the global WU-KONG28 Phase III trial of Zegfrovy in first-line non-small cell lung cancer with exon 20 insertion EGFR mutations. The data were presented as a Late-Breaking Abstract Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting and were simultaneously published in The New England Journal of Medicine.

Based on these results, a Supplemental New Drug Application has been submitted to the US Food and Drug Administration and China’s Center for Drug Evaluation for approval of Zegfrovy in the first-line setting.

Zegfrovy has also received Breakthrough Therapy Designation from both the US FDA and China’s Center for Drug Evaluation in this setting.

Sunvozertinib is included in the NCCN Clinical Practice Guidelines in Oncology for non-small cell lung cancer as a Category 2A recommended subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC.

Under the financial terms of the agreement, AstraZeneca will make an upfront payment of $600 million to Dizal. Dizal is also eligible to receive up to $900 million in additional development, regulatory and sales-related milestone payments, as well as tiered royalties on global sales of Zegfrovy.

The transaction is expected to close in the second half of 2026, subject to customary closing conditions and regulatory clearances. AstraZeneca said the agreement does not affect its financial guidance for 2026.

NSCLC
Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.2 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases.2-3 Approximately 75% of people are diagnosed with advanced NSCLC.4 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.5-7

Zegfrovy
Zegfrovy is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. Zegfrovy is approved in the US and China for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

In addition, Zegfrovy also demonstrated encouraging anti-tumour activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon 20 insertions. Zegfrovy showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related treatment-emergent adverse events were Grade 1/2 in nature and clinically manageable.

AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating in innovative approaches, the Company aims to match medicines to the patients who can benefit most.

The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso and Iressa (gefitinib); Imfinzi (durvalumab) and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan) in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action.

AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca.

References

1. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. (Version 6.2026). https://www.nccn.org/login?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed July 2026. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

2. World Health Organization. International Agency for Research on Cancer. Lung Cancer Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed August 2025.

3. American Cancer Society. What Is Lung Cancer?. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 2025.

4. Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688.

5. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27.

6. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013;6:2800-2812.

7. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013;66:79-89.

AstraZeneca Secures Global Rights to Dizal’s Oral EGFR Inhibitor Zegfrovy for Lung Cancer

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